Data / Medical devices / United States / CTL Medical Corporation

CTL Medical Corporation: FDA-registered device maker in Carrollton, TX, United States, 36 510(k) clearances

CTL Medical Corporation is registered with the FDA (registration 3009051471) in Carrollton, TX, United States. It lists 42 device types. The FDA files 36 510(k) clearances under its listings, the newest dated October 10, 2024. 2 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number

3009051471

Address

2052 McKenzie Drive, Building 1, Carrollton, TX, United States, 75006

Owner or operator

CTL Amedica (10050984)

Roles

Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer

First device listed

January 22, 2016

Registered through

2027

Brand names listed

1/4" square ratchet handle, 4 Hex Screw Cannula Driver, 4 Hex, 5 Hex Drivers, ACIF Cage Holder, ACIF Cage Impactor, ACIF Rasp, ACIF Trial, ACIF cage graft holder and more

Devices it lists

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

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Updated October 10, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.